Cleared Traditional

K053554 - COMPUFLO

K053554 is an FDA 510(k) clearance for COMPUFLO, manufactured by Milestone Scientific, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K053554 · Milestone Scientific, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
202d
Days
Class 2
Risk

K053554 is an FDA 510(k) clearance for the COMPUFLO. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Milestone Scientific, Inc. (Washington, US). The FDA issued a Cleared decision on July 10, 2006 after a review of 202 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Milestone Scientific, Inc. devices

FDA 510(k) Submission Details - K053554

510(k) Number K053554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2005
Decision Date July 10, 2006
Days to Decision 202 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 129d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 464
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K053554.
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